Parenteral solutions or other liquids may be conventionally administered to a patient from a container elevated above the patient and connected to the patient through a suitable fluid-transfer system. Such a fluid-transfer system may include a tube with a spike, cannula, or connector on one end for communication with the container interior and a hollow needle or cannula on the other end for being connected, directly or indirectly, to the patient.
One type of conventional container is blow molded from thermoplastic material, filled with the desired substance, and then hermetically sealed. Such a container is typically provided with a hanging loop on the top and a membrane on the bottom which can be pierced by a draining spike or cannula. Such containers may be provided in a generally non-collapsible form, and examples are disclosed in the U.S. Pat. Nos. 4,178,976, 4,239,726, and 4,519,513. A collapsible container suitable for medical fluids is disclosed in U.S. Pat. No. Des. 257,287.
When a container is pierced and drained through a spike, cannula, or the like, it is desirable to effect maximum drainage of the fluid contents from the container. Accordingly, it would be beneficial to provide an improved design which effectively promotes drainage of the container.
Further, in order to facilitate handling and storage of empty (drained) containers, it would be desirable to provide a container that, when empty or substantially empty, has a relatively compact configuration which accommodates such handling and storage.
Some types of hermetically sealed containers typically employ a substantially rigid, thermoplastic membrane which is adapted to be pierced by a cannula or draining spike. In such containers, the membrane size and shape can make the piercing operation difficult. There is a risk that the spike or cannula may slip off of the membrane and accidentally puncture the skin of the person who is attempting to establish the connection with the container.
Accordingly, it would be desirable to provide an improved container membrane structure for guiding the cannula, hollow needle, piercing spike, or the like during penetration of the container membrane. It would also be advantageous if such an improved membrane structure could be provided with a configuration for eliminating or minimizing the tendency of the hollow piercing instrument to "core" the membrane material which could form a plug blocking the flow through the instrument.
In some situations, it may be desirable to provide a pierceable cap or overcap with a self-sealing liner or seal that is located over the container membrane. This type of seal or liner accommodates penetration by a cannula or needle and permits subsequent removal of the cannula or needle without leaking. Such a system would permit repeated making or breaking of connections with the container. Such a system would also permit the use of a syringe needle or cannula for injecting additives or liquid agents into the container.
It would be beneficial in some applications to provide an improved, pierceable cap or overcap system with more than one site for accommodating penetration by a draining spike, cannula, syringe needle, or the like. It would be advantageous if such plural sites could each be of the self-sealing type to permit removal of the penetrating instrument without causing the container contents to subsequently leak from the container. Further, it would be beneficial if an improved penetration site in such a cap could function to provide increased forces for holding or gripping the penetrating instrument and for eliminating or minimizing leakage around the penetrating instrument.
Further, in a cap having a plurality of self-sealing penetration sites, it would be desirable to provide an overcap structure that would prevent a large draining spike from being inadvertently inserted into a penetration site intended for a smaller diameter needle or cannula.
Additionally, it would be advantageous if such a cap could optionally include exterior sealing means for sealing the penetration site or sites until the container is ready for use so as to provide a sterile and aseptic package. Such a sealing means should preferably be easily removable so as to facilitate use of the package.
Further, it would be desirable to provide a package design that would accommodate the mounting of a penetrable cap or overcap on a molded container in a way that would position the penetration region of the cap away from the molded container parting line. This would eliminate or minimize the problems that can be encountered when a piercing spike, cannula, or needle is forced against a region of the molded container where a ridge of material along the container parting line tends to inhibit penetration of the spike, cannula, or needle.
Finally, it would be beneficial if such an improved package could be readily manufactured by conventional, and relatively inexpensive, processes.
The present invention can be incorporated in a package design having many of the aforementioned benefits and features.